Method of treating urinary incontinence by implanting a reservoir around a urethra of the user

ABSTRACT

A method of treating urinary incontinence includes implanting an artificial urinary sphincter in a body of a user, where the artificial urinary sphincter has one and only one reservoir and a pump. The method includes implanting the pump in a body of the user and implanting the reservoir around a urethra of the user.

BACKGROUND

Urinary incontinence affects about 200 million people worldwide andabout 25 million people in the US. Urinary incontinence is generallymore prevalent in women than in men.

Urinary incontinence in women can be associated with a prolapse of oneor more pelvic organs, which can arise from a weakness in thetissues/muscle of the pelvic floor. Urinary incontinence in men canarise after surgical treatment of the prostate glade, which treatmentcan include removal or weakening of the prostatic sphincter associatedwith the urinary urethra.

One treatment for urinary incontinence includes placing an artificialsphincter around a portion of the urethra. The artificial sphincter hasa closed position that selectively prevents the flow of urine throughthe urethra, thus providing the user with a comfortable, continentstate. The artificial sphincter can be activated to an open position bythe user, which opens the urethra and allows the user to selectivelypass urine.

Surgeons and patients would welcome advances in the treatment of urinaryincontinence.

SUMMARY

One aspect provides an artificial urinary sphincter (AUS) systemincluding a cuff, a pump, and a conduit attachable between the cuff andthe pump. The cuff is integrated to include a first compartment and astorage compartment. The first compartment is configured to contact theurethra and the storage compartment communicates with the firstcompartment. The pump is operable to move the liquid between the firstcompartment and the storage compartment. The cuff is a pressurizablereservoir that is sized to be placed around a urethra of a user andconfigured to coapt the urethra in treating urinary incontinence.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of an artificial urinarysphincter (AUS) system implanted in the urogenital region of a malepatient.

FIG. 2 is a side view of one embodiment of a cuff of the AUS systemillustrated in FIG. 1.

FIG. 3 is a top view of the cuff of the AUS system illustrated in FIG.2.

FIG. 4 is a cross-sectional view of a portion of the cuff illustrated inFIG. 2.

FIG. 5A is a side schematic view of one embodiment of the systemillustrated in FIG. 1 in an equilibrium state configured to coapt aurethra of a user.

FIG. 5B is a side schematic view of one embodiment of the systemillustrated in FIG. 1 in an activated state allowing the urethra to passurine.

FIG. 6A is a side schematic view of one embodiment of an AUS system inan open configuration allowing the user to pass urine.

FIG. 6B is a side schematic view of the system illustrated in FIG. 6A inan activated state that closes the urethra.

FIG. 7A is a side schematic view of one embodiment of an AUS system in aclosed state that prevents the flow of urine through the urethra.

FIG. 7B is a side schematic view of the system illustrated in FIG. 7A inan activated state that opens the urethra.

FIG. 8 is a schematic view of one embodiment of an AUS system showing acuff in a simplified cross-sectional view.

FIG. 9 is a schematic view of one embodiment of an AUS system showing acuff in a simplified cross-sectional view.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

As employed in this specification, the term “end” means endmost or thevery end point of the subject being described, and the term “endportion” means that segment that is immediately adjacent to the end ofthe subject being described.

One urinary control system that has found favor with the medicalcommunity includes three components cooperatively attached withkink-resistant tubing: an occlusive cuff, a control pump, and apressure-regulating balloon reservoir. The cuff is implanted around theurethra. The control pump is implanted in the scrotum of a male user.The pressure-regulating balloon reservoir is implanted in the prevesicalspace, for example through a suprapubic incision followed by dissectionof the rectus fascia and a spreading of the linea alba. The threecomponents are filled with liquid (saline) to provide a liquid-filledclosed system maintained at an equilibrium pressure that closes the cuffaround the urethra. When the user wishes to void, he squeezes andreleases the pump several times to move fluid from the cuff into thepressure-regulating balloon reservoir. The cuff “deflates” and opens,which allows the urethra to open and pass urine. The pressure-regulatingballoon reservoir, having been pressurized to a pressure above theequilibrium pressure by action of the pump, eventually automaticallyre-pressurizes the cuff to the equilibrium pressure over the course ofseveral minutes to again inflate the cuff and coapt the urethra.

Embodiments described in this application provide an artificial urinarysphincter (AUS) system that utilizes a series of compartments (or lumensor tubes) having varying durometers. Liquid pumped into the compartmentwith the lower durometer material will cause the compartment to becomefirm or stiffer. This action can be harnessed to control the insidediameter of the AUS cuff, which allows the user to control the passageof urine.

Embodiments described in this application provide an artificial urinarysphincter (AUS) system that is provided with a conduit extending betweena cuff and a pump of the AUS system. The cuff includes at least twocompartments and one of the compartments of the cuff is configured as astorage compartment. The compartments are fabricated from materialshaving different durometers or hardness and are so configured to have anengineering material response to an equilibrium pressure level thatoperates coapt the urethra. The different hardness for the material ofeach compartment allows one compartment to operate as a storagecompartment to take up the liquid in the other compartment and store theenergy within the cuff of the system.

For example, the storage compartment integrated into the cuff is adaptedto store an additional volume of liquid. In one embodiment, the systemhas a steady state with both of the compartments pressurized and holdingliquid, which is usefully employed to coapt the urethra. The liquid inthe first compartment is movable into the storage compartment to deflatethe first compartment and allow the urethra to pass urine. The storagecompartment integrated with the cuff stores the energy of the system forsubsequent use in filling (or re-filling) the other compartment incontact with the urethra, which coapts (or re-coapts) the urethra toprovide the user with continence. The AUS system described in thispatent application is characterized by the absence of apressure-regulating balloon reservoir that would ordinarily be providedwith an artificial urinary sphincter system to store the liquid thatinflates the cuff to coapt the urethra.

The AUS system described in this patent application is suited for useboth in female patients and in male patients, where the cuff is placedaround a portion of the urethra. Female patients will have the pumpcomponent implanted in one of the labia or in an abdominal area. Malepatients will have the pump component implanted in the scrotum.

One advantage of the two-component AUS system described in this patentapplication is that the pressure-regulating balloon reservoir is doneaway with and its function is provided by the storage compartment in thecuff. Thus, fewer components are implanted into the user, which providesa smaller AUS device that is easier to implant and offers a quickerrecovery time from the implantation surgery.

FIG. 1 is a perspective view of one embodiment of an artificial urinarysphincter (AUS) system 20 illustrated as implanted in the environment ofthe male urogenital region. The AUS system 20 includes a pump 22 and aconduit 24 extending from the pump 22 to a cuff 26 that is sized to beplaced around a urethra U. The pump 22 is sized for placement within thescrotum S (as one example), and the conduit 24 is attached between thepump 22 and the cuff 26. The AUS system 20 is characterized by theabsence of a separate reservoir that is ordinarily provided to retainthe liquid that is removed from the urethral cuff to allow the user topass urine. Embodiments of the AUS system 20 configure the cuff 26 toprovide a storage compartment that stores an added volume of liquid toallow a portion of the cuff to shrink/deflate and permit the urethra toopen and pass urine.

The AUS system 20 can be referred to as a two component system, wherethe two components include the pump 22 and the cuff 26. In contrast, atypical three or more component system would include a cuff attached toa reservoir container and a pump attached to the cuff.

The cuff 26 is implanted around the bulbous urethra or around theportion of the urethra descending from the bladder neck N. The cuff 26is sized to allow placement as close to the bladder B as possible(desired by some surgeons), or positioned distal the bladder neck N assuitably determined by the surgeon. As illustrated in FIG. 1, the cuff26 is implanted around the urethra U at a location where the urethra Utransitions from a vertical orientation communicating with the bladder Bto a horizontal orientation extending to the penis P, which correspondsto the area of the urogenital region associated with an increased levelof muscle M mass.

The pump 22 is typically implanted within the scrotum S, which providesaccess to the pump 22 by the user. Other locations for placement of thepump 22 are also acceptable.

The conduit 24 is connected between the cuff 26 and the pump 22, andwhen implanted thus extends from a location in the scrotum S to alocation distal the bladder B. In one embodiment, the conduit 24 isadapted to resist kinking or bending that undesirably might impede theflow of liquid through the conduit 24.

The pump 22 is operable to move liquid within the cuff 26. In oneembodiment, the pump 22 includes a pump bulb that communicates with theconduit 24 and operates by providing suction to a portion of the cuff 26to move the cuff between a configuration that coapts the urethra U and aconfiguration that allows the urethra U to open to pass urine. Onesuitable pump is the suction style pump bulb that is illustrated thatcooperates with a valve assembly (described below) located within thecuff 26. Other suitable pump mechanisms are also acceptable, includingelectromechanical pumps, electronic pumps, button-style cavity pumps,and the like. In one embodiment, the pump 22 and the conduit 24 areintegrated into a single monolithic unit.

The conduit 24 is generally a thin-walled tube that is attachablebetween the pump 22 and the cuff 26. In one embodiment, the conduit 24is separate from the pump 22 and separate from the cuff 26 and connectsto these components through a locking mechanism, such as a quickconnector or other suitable snap-fit connector.

The system 20, when implanted, provides a closed and pressurized system.The cuff 26 is a pressure reservoir for the system 20. Specifically, thecuff 26 includes multiple compartments and one of the compartments isthe pressure reservoir of the system 20.

FIG. 2 is a side view and FIG. 3 is a top view of one embodiment of thecuff 26. The cuff 26 includes a first compartment 30 in communicationwith a storage compartment 32 and a connector 34 in communication withthe storage compartment 32. The first compartment 30 is configured andsized to be placed in contact with the urethra U. In one embodiment, thestorage compartment 32 is flexible and expandable and communicates withthe first compartment 30. For example, the storage compartment 32 issized to receive the liquid that is retained in the first compartment 30as the first compartment 30 is deflated. When the user desires to passurine, liquid is moved from the first compartment 30 into the storagecompartment 32, which results in an opening of the urethra that allowsthe user to pass urine.

The cuff 26 is placed around a portion of the urethra, for exampleduring surgery. In one embodiment, the cuff 26 includes an optionalfirst end portion 36 that provides a tab 38 and an optional second endportion 40 that is formed to include a slot 42. Insertion of the tab 38and the slot 42 forms the cuff and a substantially circular shape suitedfor placement around the urethra. Alternatively, the opposing ends ofthe cuff 26 may be sutured into position around the urethra of the user.The first compartment 30 is sized to contact most of the perimeter ofthe urethra, or the entire perimeter of the urethra, and this sizing isgenerally selected by the surgeon. The cuff 26 is generally about 2 cmwide and have varying lengths suited to different anatomical sizes,where the lengths are provided in a range between 4-11 cm.

In one embodiment, the first compartment 30 and a storage compartment 32are integrated into a single monolithic unit. It is desirable that theextension properties of the storage compartment 32 are different fromthe extension properties of the first compartment 30. Specifically, itis desirable to provide the storage compartment 32 with the level ofexpandability and/or extends ability that allows the storage compartment32 to uptake liquid from the first compartment 30. In one embodiment,the first compartment 30 is formed from a material having a firstdurometer (having units of Shore-A) and the storage compartment 32 isformed from a material having a second durometer that is different thanthe first durometer.

In one embodiment, it is desirable that the first compartment 30 is softand suitable for contact with the urethra, and that the storagecompartment 32 is more extensible than the first compartment 30. Onesuitable range hardness for the first compartment 30 is provided by amaterial having a Shore-A durometer of in a range of 50-70 Shore-A. Onesuitable range of hardness for the storage compartment 32 is provided bya material having a Shore-A durometer in a range of 10-49 Shore-A.Suitable material for fabricating the compartments 30, 32 includessilicone elastomer selected to have the appropriate value of Shore-Ahardness discussed above.

FIG. 4 is a cross-sectional view of a portion of the cuff 26. The firstcompartment 30 is in communication with the storage compartment 32 by avalve assembly 50 located in an interface wall 52. In one embodiment,the valve assembly 50 is provided as a one-way valve that allows liquidto exit the first compartment 30 and enter the storage compartment 32.Suitable valve assemblies 50 include a ball valve or a poppet valve orother such valves.

During use, liquid is stored in the first compartment 30 to provide thefirst compartment 30 with the firmness that is configured to coapt theurethra U. When the user desires to pass urine, the user operates thepump 22 (FIG. 1). The pump 22 communicates with the storage compartment32 through connection with the connector 34. The storage compartment 32communicates with the first compartment 30 through the valve assembly50. Manipulation of the pump 22 draws liquid from the first compartment30 across the valve assembly 50 and into the storage compartment 32. Inone embodiment, the actuation of the pump 22 creates a suction thatdraws liquid from the first compartment 30 across the valve assembly 50and into the storage compartment 32. In one embodiment, manipulation ofthe pump 22 causes the pressure in the storage compartment 32 toincrease, which results in the storage compartment 32 expanding awayfrom the interface wall 52.

The transfer of the liquid from the first compartment 30 into thestorage compartment 32 (for example by pumping the pump 22) results in areduction in the firmness and the first compartment 30 that removespressure that was applied against the urethra U. In this configuration,the urethra U is permitted open and pass urine.

It is desirable to return the user to a comfortable, continent statesoon after the user passes urine. In one embodiment, the interface wall52 includes one or more bleeder valves 54 a, 54 b configured to allowthe liquid stored in the storage compartment 32 to slowly flow back intothe first compartment 30. In one embodiment, the bleeder valve 54 isprovided as an orifice formed in a diaphragm, although other forms ofbleeder valve are also acceptable. In any regard, the liquid in thestorage compartment 32 (that is stored at a pressure above theequilibrium pressure of the system 20) has a pathway provided by thebleeder valve 54 that allows the system 20 to return to equilibrium. Inthe equilibrium state the liquid returns to the first compartment 30 andthe user is returned to a continent state.

FIG. 5A is a side schematic view of the system 20. The cuff 26 iswrapped around a portion of the urethra U and secured in position bycoupling the tab 38 with the end portion 40. The system 20 is anequilibrium state with the first compartment 30 and the storagecompartment 32 maintained at the same equilibrium pressure. The firstcompartment 30 is maintained at the equilibrium pressure, which isconfigured to apply a selected pressure against the urethra U that issufficient to coapt the urethra U. The system 20 provides a firstinterior cuff in the first compartment 30 that is adapted to contact theurethra U and a second cuff exterior to the interior cuff in the storagecompartment 32.

FIG. 5B is a side schematic view of the system 20 in an activated stateallowing the urethra to pass urine. The pump 22 has been manipulated todraw liquid out of the first compartment 30, through the valve assembly50, and into the storage compartment 32. An increase in pressure in thestorage compartment 32 causes the storage compartment 32 to expand orextend away from the interface wall 52. The first compartment 30 isdeflated or flaccid since liquid has been removed from the firstcompartment 30. The exposed exterior wall 60 of the storage compartment32 is more expandable than the interface wall 52, which allows thestorage compartment 32 to swell in response to the transfer of liquidfrom the first compartment 30 into the storage compartment 32. Asillustrated, the first compartment 30 is deflated and the urethra U isopened to allow urine to pass.

The bleeder valve 54 is configured to allow the pressurized liquid inthe storage compartment 32 to be subsequently transferred across theinterface wall 52 and back into the first compartment 30, which returnsthe system 22 to its equilibrium pressure.

The system 20 is designed to provide a closed system with an equilibriumpressure Pe selected to provide a sufficient pressure to coapt theurethra when the AUS system 20 is in the rest state, which ensures thatthe user is maintained in a comfortable and continent state until s/hedesires to void urine. A suitable range for equilibrium pressures Pe ofthe closed AUS system 20 is between about 30-80 cm of water. Onesuitable equilibrium pressure Pe for the AUS system 20 is about 60 cm ofwater. The storage compartment 32 is configured to expand at a storagepressure Ps that is greater than the equilibrium pressure Pe as thefirst compartment 30 is deflated. A suitable range for storage pressuresPs of the AUS system 20 is between about 85-120 cm of water. Onesuitable storage pressure Ps for the AUS system 20 is about 90 cm ofwater.

The system 20 includes the cuff 26 that is a pressure-regulating liquidstorage reservoir 26. At least a portion of the pressure-regulatingliquid storage reservoir 26 is pressurizeable to a pressure above thesteady-state equilibrium pressure of the system. The pressure-regulatingliquid storage reservoir 26 includes the storage compartment 32 thatinflates to hold the volume of liquid moved from the first compartment30, and after holding the increased pressure allows the system 20 toregulate back to the equilibrium pressure by allowing liquid to flowthrough the bleeder valves 54. The pressure-regulating liquid storagereservoir 26 is sized to be placed around a urethra of a user and isconfigured to coapt the urethra in treating urinary incontinence.

In contrast to other AUS systems that have a cuff and apressure-regulating balloon, the system 20 includes a cuff 26 that playsthe role of a pressure-regulating balloon by holding the volume ofliquid that acted to coapt the urethra (the liquid in the firstcompartment), and the pressure-regulating liquid storage reservoir 26plays the role of the cuff in that it is sized to be placed around aurethra of a user.

Other embodiments of AUS systems providing compartments having varyingdurometers are described below.

FIG. 6A is a side schematic view of one embodiment of an artificialurinary sphincter (AUS) system 100 in an open configuration allowing theuser to pass urine. FIG. 6B is a side schematic view of the system 100in an activated state that closes the urethra. The system 100 is similarto the system 20 described above but the system 100 is provided with asteady state in which the urethra U is maintained in an openconfiguration for the passage of urine. The user, to achieve a continentstate, operates the pump 22 to move liquid out of the first compartment30 and into the storage compartment 32. Thus, the system 100 willdefault to an open urethra condition if a leak develops over a period oftime and use.

In one embodiment, the material hardness for the first compartment 30 isselected to be stiff to provide the urethra with an open configuration(FIG. 6A) when the cuff 26 is in the steady state and pressurized at anequilibrium pressure Pe of about 60 cm of water. Deflating the firstcompartment 30 and pressurizing the storage compartment 32 to a storagepressure of about 90 cm of water is adapted to close the urethra toprovide the user with a continent state (FIG. 6B).

FIG. 7A is a side schematic view of one embodiment of an artificialurinary sphincter (AUS) system 200 in a closed state that prevents theflow of urine through the urethra. FIG. 7B is a side schematic view ofthe system 200 in an activated state that opens the urethra.

The system 200 includes the pump 22 attached to the conduit 24 that isattached to an inner annulus 130 of a multi-annulus cuff 126.

In one embodiment, the cuff 126 is provided with an inner annulus 130and an outer annulus 132, where the inner annulus 130 is configured as astorage compartment for the cuff 126. The conduit 124 is in fluidcommunication with the inner annulus 130. A fluid transfer valve 150 isprovided between the first annulus 130 and a second annulus 132. In oneembodiment, the fluid transfer valve 150 is provided as a one-way valvethat allows liquid to flow from the second annulus 132 into the firstannulus 130, which inflates the first annulus 130 (or the storageannulus 130).

In one embodiment, one or more bleeder valves 154 is/are located at aninterface between a first annulus 130 and a second annulus 132. Thebleeder valve 154 is provided to allow the additional liquid stored inthe first annulus 130 (or the storage annulus 130) to eventually flowand transfer back into the second annulus 132.

In the embodiment illustrated in FIGS. 7A and 7B, the first annulus 130is provided with a softer material (or a lower durometer material) ascompared to the second annulus 132. The outer, or second annulus 132 isconfigured to constrict in the steady state and close the urethra U. Thesofter material of the first annulus 130 is configured to expand whenthe liquid is transferred from the second annulus 132 and into the firstannulus 130. In this configuration, the inside diameter of the firstannulus 130 is equal to or larger than the outside diameter of theurethra U when urethra is open for the passage of urine.

FIG. 8 is a schematic view of one embodiment of an AUS system 300showing a cuff 326 in a simplified cross-sectional view as placed aroundthe urethra U. The cuff 326 includes a solid and non-inflatable annulus330 of material integrated with an inflatable compartment 332. The solidand non-inflatable annulus 330 of material is wrapped around the urethraand secured at a parting line 334. The inflatable compartment 332 iswrapped around the non-inflatable annulus 330 and is secured at aparting line 336, for example by a suture or by adhesive. The pump 22communicates with the inflatable compartment 332 by the conduit 24 thatis connected to the connector 34. The non-inflatable annulus 330 ofmaterial contacts the urethra U and is configured to reduce tissueerosion of the urethra U. In one embodiment, the non-inflatable annulus330 of material is provided as an o-ring of soft polymer and iscollapsible when the inflatable compartment 332 is pressurized orinflated by the pump 22. The cuff 326 is characterized by an absence ofinternal valves employed to harness the inflation liquid, and theinflation volume of liquid is stored in a reservoir 340.

FIG. 9 is a schematic view of one embodiment of an AUS system 400showing a cuff 426 in a simplified cross-sectional view as placed aroundthe urethra U. The cuff 426 includes a solid and non-inflatable annulus430 of material integrated with an inflatable compartment 432. Theinflatable compartment 432 is wrapped around the urethra and secured ata parting line 434. The solid and non-inflatable annulus 430 of materialis wrapped around the inflatable compartment 432 and is secured at aparting line 436, for example by a suture or by adhesive. The pump 22communicates with the inflatable compartment 432 by the conduit 24 thatis connected to the connector 34. The inflatable compartment 432contacts the urethra U and is configured to coapt the urethra wheninflated. The solid and non-inflatable annulus 430 of material providesa “backboard” of material against which the inflatable compartment 432pushes, which allows the inflatable compartment 432 to effectively coaptthe urethra U at a lower inflation pressure (for example, at aninflation pressure of 20-30 cm of water). In one embodiment, thenon-inflatable annulus 430 of material is provided as a solid o-ring ofpolymer material, such as silicone or urethane or a polyolefin such aspolyethylene or polypropylene. The cuff 426 is characterized by anabsence of internal valves and the like, however the inflation volume ofliquid is stored in a reservoir 440.

A method of treating a patient suffering from urinary incontinenceincludes a surgical procedure to implant any one of the systemsdescribed above. The patient is prepared for surgery in a mannerprescribed by the hospital or clinic as supervised and approved by thesurgeon. The perineal area of the patient is cleaned with suitablecleansers and prepared for surgery. A perineal incision is made on themidline of the patient, and tissue is dissected to expose thebulbospongiosus muscle supporting the urethra U. The surgeon willdissect laterally to free the fascia around the bulbospongiosus muscleand expose a portion of the length of the urethra U. The bulbospongiosusmuscle is immobilized, for example by clamping laterally to each side ofthe patient, which exposes the urethra. The surgeon dissects additionaltissue and muscle by “tunneling” around the posterior side of theurethra to create a pathway around a circumference of the urethra. Thecuff 26 is traversed along the pathway around the urethra U until aportion of the cuff 26 is posterior to the urethra U with the tab 36 anda slot 42 of the cuff 26 anterior to the urethra U. The tab 36 isinserted into the slot 42 to secure the cuff 26 around the urethra U. inother embodiment, the cuff is directed around the urethra and suitablesutured or otherwise secured in position.

The surgeon typically confirms performance of the implanted cuff byinjecting liquid into the connector 34. The tube 26 and the pump 22 areattached to the cuff 26. For example, the pump 22 is located in thescrotum (male) or labia (female) of the user and the tube 26 isconnected between the pump and the cuff 26 that has been placed aroundthe urethra U. The surgeon will pressurize the system 20 and equilibriumpressure Pe and cause the cuff 26 to coapt the urethra U. The surgeonwill confirm that operation of the pump 22 will move liquid into or fromthe cuff 26, depending upon the embodiment, thus opening the urethra Uand allowing the patient to pass urine. The surgical site is closedafter confirmation of performance of the system 20.

Embodiments of methods of treating a patient suffering from urinaryincontinence with the system 20 include providing an implantable deviceto treat urinary incontinence, the device including apressure-regulating liquid storage reservoir, a pump, and a conduitattachable between the pressure-regulating liquid storage reservoir andthe pump; and implanting the pressure-regulating liquid storagereservoir around at least a portion of a urethra of a user.

Embodiments of methods of treating a patient suffering from urinaryincontinence with the system 20 include creating a perineal incision ina patient; and inserting a pressure-regulating liquid storage reservoirthrough the perineal incision and implanting the pressure-regulatingliquid storage reservoir around at least a portion of a urethra of auser.

Embodiments of the artificial urinary sphincter (AUS) system describedabove include a fully functional system for treating urinaryincontinence that operates in the absence of a reservoir providedseparate from the tubing, cuff, and pump. The tube or tubing isconnected between the cuff and the pump and includes a lumen that isconfigured to expand to provide the lumen/system with an inflatablestorage compartment.

Although specific embodiments have been illustrated and described inthis patent application, it will be appreciated by those of ordinaryskill in the art that a variety of alternate and/or equivalentimplementations may be substituted for the specific embodiments shownand described without departing from the scope of the invention. Thispatent application is intended to cover any adaptations or variations ofmedical devices, as discussed above. Therefore, it is intended that thisinvention be limited only by the claims and their equivalents.

What is claimed is:
 1. A method of treating urinary incontinence, themethod comprising: implanting one and only one reservoir in a body of auser by placing the reservoir around a urethra of the user, where thereservoir includes a first compartment and a storage compartment havinga pathway communicating with the first compartment; placing a liquid inthe reservoir; implanting a pump in the body of the user, with the pumpcommunicating with the reservoir; operating the pump and moving theliquid from the first compartment to the storage compartment thusrelieving a constriction of the urethra and allowing the user to passurine through the urethra; and configuring the reservoir to move theliquid from the storage compartment through the pathway to the firstcompartment and constricting the urethra of the user in providing theuser with urinary continence.
 2. The method of claim 1, wherein theoperating the pump and moving the liquid from the first compartment tothe storage compartment comprises pressurizing the storage compartmentat a pressure that is greater than a pressure in the first compartment.3. The method of claim 1, wherein the constricting the urethra of theuser in providing the user with urinary continence comprises forming anequilibrium pressure in the reservoir characterized in a first pressurein the first compartment being equal to a second pressure in the storagecompartment.
 4. The method of claim 3, wherein the operating the pumpand moving the liquid from the first compartment to the storagecompartment comprises disrupting the equilibrium pressure andpressurizing the storage compartment such that the second pressure inthe storage compartment is greater than the first pressure in the firstcompartment in the reservoir.
 5. The method of claim 1, wherein theplacing the reservoir around the urethra of the user comprisesimplanting the first compartment closer to the urethra than the storagecompartment is to the urethra.
 6. The method of claim 1, wherein theoperating the pump and moving the liquid from the first compartment tothe storage compartment comprises expanding a size of the storagecompartment.
 7. A method of treating urinary incontinence, the methodcomprising: implanting a closed system in a body of a user, where theclosed system comprises one and only one reservoir connected to a pump,and the reservoir includes a first compartment and a storage compartmenthaving a pathway communicating with the first compartment; implantingthe pump in a body of the user and implanting the reservoir around aurethra of the user by locating the first compartment of the reservoircloser to the urethra of the user than the storage compartment is to theurethra of the user; and pressurizing the reservoir to an equilibriumpressure, constricting the urethra of the user, and providing the userwith urinary continence.
 8. The method of claim 7, wherein thepressurizing the reservoir to the equilibrium pressure comprisespressurizing the first compartment and the storage compartment to anequal pressure.
 9. The method of claim 7, further comprising: operatingthe pump and moving the liquid from the first compartment to the storagecompartment thus relieving a constriction of the urethra and allowingthe user to pass urine through the urethra.
 10. The method of claim 7,further comprising: operating the pump and moving the liquid from thefirst compartment to the storage compartment and pressuring the storagecompartment at a storage pressure that is higher than the equilibriumpressure.
 11. The method of claim 10, further comprising: providing ableeder valve connected between the storage compartment and the firstcompartment of the reservoir, and moving the liquid in the storagecompartment through the bleeder valve and returning the storagecompartment to a pressure equal to the equilibrium pressure.
 12. Amethod of treating urinary incontinence, the method comprising:implanting an artificial urinary sphincter in a body of a user, wherethe artificial urinary sphincter has one and only one reservoir and apump; implanting the pump in a body of the user, implanting thereservoir around a urethra of the user, and connecting the pump to thereservoir with a section of tubing; and pressurizing the reservoir to anequilibrium pressure with a liquid, constricting the urethra of theuser, and providing the user with urinary continence.
 13. The method ofclaim 12, further comprising: operating the pump and moving the liquidinto a storage compartment of the reservoir and relieving a constrictionof the urethra allowing the user to pass urine through the urethra.